
Omega Laboratories, Inc.
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OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES is an FDA 510(k)-cleared medical device (K112808) manufactured by Omega Laboratories, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 22, 2012. Regulation: 8.